Thyroid Medication Recall: Vitruvias 30 mg Tablets Recalled Nationwide Over Superpotency Risk
Thyroid medication recall: Vitruvias Therapeutics is voluntarily recalling one lot of its Thyroid Tablets, USP 30 mg after testing found the product could be superpotent, meaning it may contain more thyroid hormone activity than intended.
The recall affects Lot 504950, which was distributed nationwide in the United States. The FDA published the recall notice on August 24, 2026, following the company’s August 21 announcement.
Patients who have the recalled lot should not stop taking the medication on their own. The company advises patients to contact their healthcare provider for guidance and, if appropriate, a replacement prescription.
Which thyroid medication is being recalled?
The nationwide recall involves the following product:
| Recall Detail | Information |
|---|---|
| Product | Thyroid Tablets, USP 30 mg |
| Company | Vitruvias Therapeutics, Inc. |
| NDC | 69680-166-00 |
| Lot Number | 504950 |
| Expiration Date | September 30, 2026 |
| Units Released | 3,655 |
| Units Sold | 1,955 |
| Distribution | Nationwide in the U.S. |
| Distribution Period | January 31, 2025 – September 30, 2025 |
The recall is limited to one lot: 504950.
Vitruvias said the affected lot was distributed to its direct accounts nationwide between January 31 and September 30, 2025.
Why was the thyroid medication recalled?
The company initiated the recall after testing confirmed the potential for the tablets to be superpotent.
Superpotent thyroid medication can expose patients to excessive levels of thyroid hormones. This may result in hyperthyroidism, or an overactive thyroid.
Possible symptoms can include:
- Weight loss
- Heat intolerance
- Fatigue
- Nervousness
- Muscle weakness
- High blood pressure
- Chest pain
- Rapid heart rate
- Abnormal heart rhythm
The risk may be greater for older adults, pregnant women and infants, particularly when excessive thyroid hormone exposure continues for an extended period.
According to Vitruvias, the company has not received any reports of adverse events known to be associated with this recall as of its announcement.
What is Thyroid Tablets, USP 30 mg used for?
Thyroid Tablets, USP is a natural thyroid hormone preparation derived from porcine thyroid glands.
It contains two thyroid hormones:
- Levothyroxine (T4)
- Liothyronine (T3)
The medication is used as replacement or supplemental therapy for people with hypothyroidism, a condition in which the body does not produce enough thyroid hormone.
Because thyroid hormones affect metabolism, heart function and other body systems, taking more than the intended amount can cause symptoms associated with an overactive thyroid.
What should patients do if they have the recalled lot?
Patients should first check the product packaging to determine whether their medication is:
Thyroid Tablets, USP 30 mg — Lot 504950
If the lot number matches the recalled product, patients should not discontinue treatment without speaking with their healthcare provider.
Vitruvias recommends contacting a doctor or other healthcare professional for guidance and a replacement prescription if necessary.
The company is also contacting wholesalers and asking them to stop distributing the recalled product. It is arranging for the recalled tablets to be destroyed.
Who may face a higher risk?
The FDA and Vitruvias specifically identify several groups that may be more vulnerable to excessive thyroid hormone exposure:
Older adults: Excess thyroid hormone can have potentially serious effects on the cardiovascular system.
Pregnant women: Overtreatment of hypothyroidism during pregnancy has been associated with increased maternal and fetal complications, including premature delivery and low birth weight.
Infants: Excess thyroid hormone exposure may negatively affect growth and development.
This does not mean every person who took the recalled medication will experience these problems. The concern is specifically related to the potential for the recalled tablets to be more potent than intended.
How can consumers contact Vitruvias Therapeutics?
Consumers with questions about the recall can contact Vitruvias Therapeutics directly:
Phone: 256-239-9373
Hours: Monday–Friday, 9 a.m.–5 p.m. CT
Email: safety@vitruvias.com
People who experience a suspected adverse reaction or quality problem can also report it through the FDA’s MedWatch safety reporting program.
What does the FDA recall mean?
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Importantly, the FDA’s recall notice identifies the issue as a potential superpotency problem involving one specific lot, rather than a recall of every Vitruvias thyroid tablet.
Patients should therefore check the lot number and product information before assuming their medication is affected.
The bottom line
Vitruvias Therapeutics has recalled one nationwide lot of Thyroid Tablets, USP 30 mg (Lot 504950) because testing found the potential for the product to be superpotent.
The affected lot has NDC 69680-166-00, an expiration date of September 30, 2026, and 1,955 units were sold after 3,655 units were released.
Anyone who finds Lot 504950 in their possession should contact a healthcare provider before stopping the medication and follow the provider’s instructions regarding replacement treatment.
Sources: U.S. Food and Drug Administration (FDA), Vitruvias Therapeutics, Inc.
